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Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children

Primary Purpose

Pediatric Pulmonary Hypertension

Status
Completed
Phase
Phase 4
Locations
Indonesia
Study Type
Interventional
Intervention
Beraprost Sodium
Sildenafil Citrate
Sponsored by
Dr. Soetomo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Pulmonary Hypertension

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosed as pulmonary hypertension with left to right shunt CHD (VSD, ASD, PDA and combination)
  • agree to enroll in this study

Exclusion Criteria:

  • suffer from chronic lung disease
  • suffer from soft tissue tumor, HIV/AIDS
  • under interferon therapy
  • already performed any cardiac surgery
  • already got anti-PH remedy

Sites / Locations

  • Dr. Soetomo General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Beraprost Sodium

Sildenafil citrate

Arm Description

Beraprost 1mcg/kg/day, divided in 3 doses orally patient was followed up for 12 weeks, then echocardiography evaluation was performed in patient completed the study. 22 patients

Sildenafil 0.4 mg/kg/time, 4 times daily per oral patient was followed up for 12 weeks, then echocardiography evaluation was performed in patient completed the study. 20 patients

Outcomes

Primary Outcome Measures

Efficacy of Beraprost, Sildenafil and comparison between both drugs in lowering pulmonary arterial pressure
Measuring mPAP (pre-post therapy) via echocardiography before and after consuming sildenafil or beraprost

Secondary Outcome Measures

Emergent Adverse Events
adverse event reported by patients and during weekly examination after consuming Beraprost or Sildenafil: hypotension, dizzy, headache, flushing, bleeding

Full Information

First Posted
July 29, 2017
Last Updated
February 12, 2018
Sponsor
Dr. Soetomo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03431649
Brief Title
Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children
Official Title
Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Pulmonary Arterial Hypertension Children Associated With Left to Right Shunt Congenital Heart Defect
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
July 30, 2017 (Actual)
Study Completion Date
October 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Soetomo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To analyze the efficacy of beraprost and sildenafil for treatment of pulmonary hypertension in children with left to right shunt. analyze the efficacy and side effects.
Detailed Description
Eligibility criteria: Inclusion: children aged 1-17 years with left to right shunt, diagnosed as pulmonary hypertension. free from chronic pulmonary disease never performed any cardiac surgical never got any treatment for PH agree to enroll in this study. Exclusion 1. suffer from portal hypertension, HIV and connective tissue disease 2. under interferon therapy. Outcome measure: Pulmonary artery pressure

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Pulmonary Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
the researchers don't know which drug taken by the patient and don't know the previous PA pressure
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Beraprost Sodium
Arm Type
Experimental
Arm Description
Beraprost 1mcg/kg/day, divided in 3 doses orally patient was followed up for 12 weeks, then echocardiography evaluation was performed in patient completed the study. 22 patients
Arm Title
Sildenafil citrate
Arm Type
Active Comparator
Arm Description
Sildenafil 0.4 mg/kg/time, 4 times daily per oral patient was followed up for 12 weeks, then echocardiography evaluation was performed in patient completed the study. 20 patients
Intervention Type
Drug
Intervention Name(s)
Beraprost Sodium
Other Intervention Name(s)
Dorner
Intervention Description
1 mcg /kgbw daily, divided in three dosages orally for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Sildenafil Citrate
Other Intervention Name(s)
Viagra
Intervention Description
0.4 mg/kgbw each time, 4 times in a day orally for 12 weeks
Primary Outcome Measure Information:
Title
Efficacy of Beraprost, Sildenafil and comparison between both drugs in lowering pulmonary arterial pressure
Description
Measuring mPAP (pre-post therapy) via echocardiography before and after consuming sildenafil or beraprost
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Emergent Adverse Events
Description
adverse event reported by patients and during weekly examination after consuming Beraprost or Sildenafil: hypotension, dizzy, headache, flushing, bleeding
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosed as pulmonary hypertension with left to right shunt CHD (VSD, ASD, PDA and combination) agree to enroll in this study Exclusion Criteria: suffer from chronic lung disease suffer from soft tissue tumor, HIV/AIDS under interferon therapy already performed any cardiac surgery already got anti-PH remedy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahrus Rachman, MD
Organizational Affiliation
Dr. Soetomo General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Dr. Soetomo General Hospital
City
Surabaya
State/Province
East Java
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
16132278
Citation
Limsuwan A, Pienvichit P, Khowsathit P. Beraprost therapy in children with pulmonary hypertension secondary to congenital heart disease. Pediatr Cardiol. 2005 Nov-Dec;26(6):787-91. doi: 10.1007/s00246-005-0925-4.
Results Reference
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Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children

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